DIVERSITY, EQUITY & INCLUSION Sponsors and CRO companies were also
asked to provide National Clinical Trial (NCT) numbers. Using
ClinicalTrials.Gov, Tufts CSDD researchers next collected and compiled demographic data for protocols that had a corresponding NCT number. For this study, demographic diversity included participant sex, racial identity, and ethnicity (Hispanic or not Hispanic), as these are the most commonly reported. Trial demographic descriptive statistics (mean, coefficient of variance, median, and range) were calculated overall, and mean and coefficients of variation were calculated for the DCT solutions used. T-tests were performed to test for significant differences in demographic subgroups between trials when specific DCT solutions were used and when they weren’t. Data were collected and stored as an Excel spreadsheet and analysed using SAS 9.4.
Study findings In total, Tufts CSDD researchers evaluated 331 protocols which provided various amounts of DCT solution and participant demographic data, the majority of which were phase II and III studies. Protocols in the sample were nearly evenly divided between small molecule therapies and biologics. Immunology/rheumatology and oncology were the most common therapeutic areas. On average, male participants made up
slightly more than half (52.9%) of the patients enrolled in the clinical trials evaluated. The
majority of enrolled patients were white (73.5%); Asian participants made up the next largest racial demographic (15.9%) group. Patients who identified as Black or of African Descent comprised 9.8% of the total. Approximately one out of eight participants (12.7%) were identified as Hispanic or Latino. The results showed that when one or more
DCT solution was used in a clinical trial, the percentage of white participants was lower — 72.7% — compared to 81.3% in clinical trials where no DCT solution was used (t-test, p = .0455). No other significant differences were observed in this comparison. When virtual or televisits were used in a clinical trial, the percentage of Black participants enrolled was significantly lower, from 11.4% in clinical trials with no virtual or televisits, to 5.5% in clinical trials with virtual or televisits (t-test, p = .0023). Other demographic subgroups did not show any significant differences. No significant differences were found in
demographic distributions for clinical trials with and without mobile or wearable devices. Significant differences were observed, however, between clinical trials that used local labs and those that did not. Among clinical trials that used local labs, the percentage of white participants was significantly lower (t-test, p = .0354). The percentage of multiracial participants was also lower in clinical trials that used local labs than in those that did not (t-test, p = .0006).
Credit: Dmytro Zinkevych via Shutterstock. 58 | Outsourcing in Clinical Trials Handbook
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